A Comparison of Stryker Hybrid Arch Bars Versus Erich Arch Bars for Maxillomandibular Fixation of Mandibular Fractures: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to Place Archbars
研究概览
简要总结
Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth together or using small titanium plates and screws to fix the fracture. With either technique the upper and lower teeth are held together to ensure that the fracture is held in the correct position during healing (for closed reduction) or while the plate and screws are applied (for open reduction).
The teeth can be held together using Erich arch bars which are a type of braces that are temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture has healed even though the patient is able to open his mouth immediately after the surgery is complete. The alternative to the traditional Erich arch bars is a relatively new type of arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The purpose of this study is to compare the two types of arch bars in terms of the speed with which they can be applied as well as any difference in fracture healing
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis
- •Age 18 years - 90 years
- •Ability to give informed consent
- •Minimum 6 weeks follow-up
- •Pre and post-operative panoramic xrays
排除标准
- •Comminuted fractures
- •Infected fractures
- •Previously treated fractures
- •Complete edentulism
- •Gun shot wounds
- •Pregnancy or breast feeding
结局指标
主要结局
Time to Place Archbars
时间窗: During initial admission and surgery
Time taken to place archbars
次要结局
- Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures(up to 6 weeks post operatively)
- Number of Participants With Fracture Healing at 6 Weeks(6 weeks)
研究者
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS
Associate Professor
Emory University
